Overview

A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Altavant Sciences GmbH
Criteria
Inclusion Criteria:

- Male and female 18 years or older

- Body Mass Index (BMI) 18kg/m2 to 38kg/m2

- Symptomatic PAH belonging to WHO Group 1 on a stable treatment regimen with one or
more approved PAH treatments

- PAH defined as mean pulmonary artery pressure ≥ 20 mmHg during right heart
catheterization performed at rest

- FEV1 ≥ 60 % of predicted normal, FEV1:FVC ratio ≥ 0.70 or TLC ≥ 70% of predicted
normal

- WHO FC II or III

Exclusion Criteria:

- Pregnant women

- WHO Pulmonary Hypertension (PH) Group 2 - 5

- PAH associated with significant venous or capillary involvement (PCWP > 15 mmHg),
pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital
heart defects (CHD))

- Three or more risk factors for left ventricular disease; BMI ≥ 30 kg/m^2, diagnosis of
essential hypertension that is actively treated, diabetes mellitus, history of
significant coronary artery disease, atrial fibrillation, and/or left atrial volume
index > 41 mL/m^2

- Known genetic hypertrophic cardiomyopathy, or cardiac sarcoidosis or amyloidosis

- The patient has a history of, or currently has, a constrictive cardiomyopathy

- Known history of any LVEF < 40% by echocardiogram within 3 years of randomization

- Hemodynamically significant valvular heart disease

- Patient severely disabled and unable to complete the study

- End stage renal disease or severe liver disease

- Known congenital long QT syndrome (LQTS) or known family history of LQTS

- Depression that is currently rated as severe or recent suicidal behavior or active
suicidal ideation with intent to act

- Uncontrolled arterial hypertension or hypotension

- Patients currently taking one or more drugs known to prolong the QT interval and which
are clearly associated with a known risk of Torsades de Pointe

- QTcF interval > 450 ms for males or > 470 ms for females

- Any ECG or clinical laboratory abnormality which precludes safe participation in the
study in the opinion of the Investigator